Virtual Reality-Based Rehabilitation in Chronic Low Back Pain: Effects on Muscle Architecture, Balance, and Satisfaction (VR-LBPREHAB)

Официальное название

Investigation of the Effects of Virtual Reality-Based Rehabilitation on Muscle Architecture, Balance Control, and Patient Satisfaction in Individuals With Chronic Low Back Pain

Обзор

Chronic low back pain is a common musculoskeletal disorder that causes pain, disability, and reduced quality of life. It is often related to changes in trunk muscle function, thoracolumbar fascia morphology, and impaired balance control. Although conventional motor control exercises are effective, patient motivation and adherence can be limited. Virtual reality (VR)-based rehabilitation offers interactive and engaging environments that may improve compliance and provide additional therapeutic benefits. This study is a randomized controlled trial designed to investigate the effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. A total of 40-50 participants aged 18-65 will be recruited and randomly assigned to one of two groups: (1) VR-based rehabilitation or (2) conventional exercise therapy. Both programs will last 8 weeks, delivered three times per week for 40 minutes per session. The primary outcomes include muscle architecture assessed by ultrasound imaging, thoracolumbar fascia morphology, and postural balance control measured by force platform tests. Secondary outcomes include pain intensity, disability, fear-avoidance beliefs, quality of life, and patient satisfaction. The findings of this study are expected to provide new insights into the role of VR in rehabilitation and contribute to evidence-based strategies for managing chronic low back pain. By exploring the effects on both physical and patient-reported outcomes, the study may highlight innovative approaches to improve adherence, reduce pain, and enhance daily function in affected individuals.

Подробное описание

Chronic low back pain is a prevalent musculoskeletal condition associated with altered muscle activation, impaired postural control, and thoracolumbar fascia changes that may contribute to persistent pain and disability. Conventional rehabilitation approaches such as stabilization and motor control exercises are widely recommended, yet patient adherence and motivation often limit their effectiveness.

Virtual reality (VR)-based rehabilitation integrates visual, auditory, and interactive elements that can enhance engagement, provide distraction from pain, and encourage more consistent exercise participation. While VR interventions have shown benefits in populations such as stroke, cerebral palsy, and multiple sclerosis, the evidence in chronic low back pain remains limited.

This randomized controlled trial is designed to investigate the clinical and functional effects of VR-based rehabilitation compared with conventional motor control exercises in individuals with chronic low back pain. The intervention will combine traditional physiotherapy approaches with VR-based exercises to evaluate potential improvements in muscle architecture, balance control, and patient-centered outcomes such as satisfaction and adherence.

The study will contribute novel data on the feasibility and effectiveness of VR-based rehabilitation in chronic low back pain, with the goal of providing physiotherapists and clinicians with evidence to guide innovative treatment strategies. The adapted approach is expected to promote adherence, improve functional outcomes, and address gaps in the current literature on VR applications in musculoskeletal rehabilitation.

Вмешательства

• Поведенческое Virtual Reality-Based Rehabilitation
  Participants receive 20 minutes of motor control exercises combined with 20 minutes of Pilates-inspired virtual reality games (5 repetitions per set). Training will be delivered three times per week, 40 minutes per session, for 8 weeks (24 sessions in total).
• Поведенческое Conventional Motor Control Exercises
  Participants perform 40 minutes of progressive spinal stabilization and motor control exercises (10 repetitions per set), three times per week for 8 weeks (24 sessions in total).

Первичные конечные точки

• Change in Transversus Abdominis Thickness (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Internal Oblique Thickness (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in External Oblique Thickness (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Rectus Abdominis Thickness (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Thoracolumbar Fascia Thickness (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Thoracolumbar Fascia Morphology (categorical) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Postural Sway (mm) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Limits of Stability (mm/°/s) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]

Вторичные конечные точки (11)

• Pain Intensity [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Functional Disability [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Functional Disability [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Lumbar Paravertebral Muscle Stiffness (N/m) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Lumbar Paravertebral Muscle Elasticity (ratio) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Trunk Muscle Endurance (mmHg, seconds) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Fear-Avoidance Beliefs [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Change in Quality of Life (Nottingham Health Profile Total Score) [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]
• Patient Satisfaction [Срок оценки: 8 weeks, 3 months, 6 months.]
• Exercise Adherence [Срок оценки: During the 8-week intervention.]
• Body Composition [Срок оценки: Baseline, 8 weeks, 3 months, 6 months.]

Критерии участия

Критерии включения

• Age 18-65 years.
• Chronic low back pain persisting for ≥ 3 months.
• Literacy and Montreal Cognitive Assessment (MoCA) score > 21.
• Voluntary participation with signed informed consent.

Критерии исключения

• Malignancy.
• Pregnancy.
• History of epilepsy (including photosensitive seizures), dementia, migraine, or other neurological disorders limiting VR use.
• Surgery within the past 6 months.
• Received physiotherapy or rehabilitation services in the past 6 months.
• Presence of acute infection.
• Unhealed fracture.
• Withdrawal of informed consent at any stage of the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Hacettepe University — Ankara

Публикации

• Taguchi T, Tesarz J, Mense S. The thoracolumbar fascia as a source of low back pain. In: Fascia Research II - Basic Science and Implications for Conventional and Complementary Healthcare. Munich: Elsevier GmbH; 2009:251.
• Li R, Li Y, Kong Y, Li H, Hu D, Fu C, Wei Q. Virtual Reality-Based Training in Chronic Low Back Pain: Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Med Internet Res. 2024 Feb 26;26:e45406. doi: 10.2196/45406. PMID 38407948
• Brea-Gomez B, Torres-Sanchez I, Ortiz-Rubio A, Calvache-Mateo A, Cabrera-Martos I, Lopez-Lopez L, Valenza MC. Virtual Reality in the Treatment of Adults with Chronic Low Back Pain: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Int J Environ Res Public Health. 2021 Nov 11;18(22):11806. doi: 10.3390/ijerph182211806. PMID 34831562
• Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. PMID 29573870
• Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012 Jun;64(6):2028-37. doi: 10.1002/art.34347. Epub 2012 Jan 9. PMID 22231424

Идентификаторы

NCT: NCT07172828 · FTREK25/40

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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